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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857285
First Posted: March 6, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.
Results First Submitted: May 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: olmesartan medoxomil
Drug: losartan potassium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.

Reporting Groups
  Description
Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks

Participant Flow:   Overall Study
    Olmesartan Medoxomil   Losartan Potassium
STARTED   65   65 
COMPLETED   53   59 
NOT COMPLETED   12   6 
Adverse Event                4                2 
Lack of Efficacy                0                2 
Protocol Violation                3                1 
Withdrawal by Subject                4                0 
Randomization criteria not met                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks
Total Total of all reporting groups

Baseline Measures
   Olmesartan Medoxomil   Losartan Potassium   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   65   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.63  (10.69)   48.34  (9.17)   48.98  (9.94) 
Gender 
[Units: Participants]
     
Female   33   23   56 
Male   32   42   74 
Race/Ethnicity, Customized 
[Units: Participants]
     
Taiwanese   65   65   130 
Region of Enrollment 
[Units: Participants]
     
Taiwan   65   65   130 


  Outcome Measures

1.  Primary:   Mean Change of Sitting dBP From Baseline to Week 12   [ Time Frame: Baseline to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Regulatory Operations
Organization: Daiichi Sankyo, Inc.
phone: 732-590-5000
e-mail: hmkessler@dsus.com



Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
ClinicalTrials.gov Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: May 28, 2009
Results First Posted: July 23, 2009
Last Update Posted: July 29, 2009